NCT07471230
Not yet recruiting
Phase 2
Phase II Randomized Controlled Trial Evaluating Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism
Biocells Medical1 site in 1 country120 target enrollmentStarted: November 23, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Biocells Medical
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- NMSS
Overview
Brief Summary
This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.
The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 48 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months
Exclusion Criteria
- •Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression
Arms & Interventions
Neuroinduced Mesenchymal Stem Cells
Experimental
200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
Intervention: Intrathecal (IT) (Biological)
Mesenchymal Stem Cell Derived Exosomes
Experimental
1×10¹¹ particles per infusion
Intervention: Intravenous (Biological)
Intravenous saline infusion
Placebo Comparator
Intervention: Intravenous (Biological)
Outcomes
Primary Outcomes
NMSS
Time Frame: 48
Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least
Secondary Outcomes
- MDS-UPDRS(48)
Investigators
Study Sites (1)
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